The quantitative determination of analytes in body fluids is of great importance in the diagnoses and maintenance of certain physiological conditions. For example, individuals with diabetes frequently check the glucose level in their bodily fluids. The results of such tests can be used to regulate the glucose intake in their diets and/or to determine whether insulin or other medication needs to be administered.
Diagnostic systems, such as blood-glucose systems, may employ a meter or instrument to calculate the glucose value in a blood sample from an individual. Such instruments operate by measuring an output, such as current or color, from a reaction with the glucose in the sample. The test results typically are displayed and stored by the meter. Basic systems allow the user to access the test results directly from the meter via a keypad or other interactive component.
Other diagnostic systems, however, provide more advanced functionality to allow a user to process and manage test results. For example, some systems allow a user to load test results from a blood-glucose meter onto a processing device, such as a conventional desktop personal computer (PC), and to process and display the results with a data-management application. However, using the processing power of PC technology to organize results from a blood-glucose meter is just one example of how diagnostic systems provide more functionality by incorporating different technologies into a diagnostic process.
Although integrating different technologies and functions may yield highly sophisticated and extremely useful diagnostic systems, the introduction of such systems into the marketplace is slowed by current approaches to product design and development in the industry. For example, current approaches to the design of multi-function products employ complicated system architectures that interconnect the variety of functional elements via distinct and non-standard techniques. Accordingly, a functional element must be developed with the specific final product and the other functional elements in mind. In other words, the complex architecture results in dependencies between functional elements, and thus does not allow each element to be developed independently and/or in parallel. As such, the development process requires more time as more components are added and complexity is increased.
In addition, although the final integrated product may provide the features and advantages of a variety of technologies, the rapid pace of change in these technologies may outdate the final product before the final product is introduced to the market, particularly because product development takes such a long time. In other words, current approaches to product development make it difficult to ensure that the users of the product have the latest generation of technology. Where the cost of integrated products may be relatively high due to the greater amount of functionality, consumers may find less justification in purchasing such products when their technology may become quickly outdated.
In view of the foregoing, there is a need for design and development approaches that simplify the process of combining different technological components into a single product while meeting the high quality standards for medical devices. In particular, there is a need for an approach that simplifies interfaces between components and therefore permits different combinations of components to be easily and reliably integrated regardless of the number of components. Moreover, there is a need for an approach that allows the final product to be dynamically and continuously updated to offer its users the most current technology.